Organophosphorus PoisoningNCT06256796
Fresh Frozen Plasma Transfusion in Acute Organophosphate Poisoning
A study testing fresh frozen plasma in people with Organophosphorus Poisoning, run by Ain Shams University at 1 site in Egypt.
Trial summary
this study clinical trial to assess the role of fresh frozen plasma as a novel available and easy to be applied rather than conventional therapy on organophosphate poisoned patients and prediction of it is prognosis on selected patients and it is effect on outcome . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Organophosphorus Poisoning
- What is being tested?
- fresh frozen plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -moderate and severe degree of organophosphate poisoning will be included in this study.
Who cannot join
- patients below 18 years or above 60 years.
- Patients with history of diabetes, cardiac disease, respiratory, renal disease and hepatic disease.
- Pregnant female
- Patients suspected of having mixed or unknown exposure
- Patients with coagulation disorders.
- Patients with hyper sensitivity to FFP or plasma derived products, as these cases are contraindicated to take fresh frozen plasma
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of medicine Ain Shams University
Cairo
Somaia Anwar, assistant lecture, 00201011327681, dr_somaiaanwr@med.asu.edu.eg
Soha Ashry, professor, 01114041404
About this study
Official title: Evaluation of Effectiveness of Fresh Frozen Plasma Transfusion as a Novel Adjuvant Treatment in Acute Organophosphate Poisoned Patients. A Randomized Clinical Trial in Poison Control Center Ain Shams University Hospital.
this study clinical trial to assess the role of fresh frozen plasma as a novel available and easy to be applied rather than conventional therapy on organophosphate poisoned patients and prediction of it is prognosis on selected patients and it is effect on outcome .
Read the detailed description
a prospective randomized clinical trail study . this study will be conducted in poison control center Ain shas university hospital -Egypt . all adult patients of both sexes admitted , in Poison Control Center of Ain Shams University Hospitals (PCC-ASUH) with diagnosis of moderate and severe degree of organophosphate poisoning will be included in this study.
The severity of patients under the study will be assessed at the time of presentation using the PeradeniyaOrganophosphorus Poisoning (POP) scale The severity will be graded as mild(0-3), moderate (4-7), and sever (8- 11).
The included patients in this study will be randomly divided into two groups as follow:
Group A: Patients who will be treated according to traditional management protocol of OPC toxicity in the form of: supportive measures, decontamination and antidotal therapy (atropine \&Oximes) as follow:
- Supportive measures and patients resuscitation.
- Decontamination: patients presenting within 4hr of OP ingestion will be subjected to gastric lavage and all patients with oral exposure will be given a single (30 mg) dose of activated charcoal. Any contaminated material will be discarded and dermal contamination will be carried out using soap and water,if necessary.
- Antidotal therapy: Atropine(each ampoule contains 1mg of atropine per ml) will be given as bolus doses of 2-5 mg IV and repeated every10-15 min until dryness of chest secretions, and then atropine injections maintenance doses will be given intermittently to patients as needed .Toxogonin (each ampoule contains 250mg of obidoxime chloride in 1 ml, produced by Merck, Darmstadt, Germany)will be administered as a loading dose of 250 mg, and will be repeated every 8 hrs until at least 12hrs after atropine no longer required.
This group of patients will be divided in to :
GroupA1 will include moderate degree of acute OP poisoned patients (POP scale 4-7) Group A2 will include severe degree of acute OP poisoned patients (POP scale 8-11)
Group B: Patients who will be treated with conventional therapy of OPC toxicity in the form of: supportive measures, decontamination and antidotal therapy (atropine \&Oximes) in addition to fresh frozen plasma (FFP).
FFP will be given after one hour of hospitalization (time needed to prepare FFP to the patients and to finish emergency management) in dose of 20ml\kg given as follows:
- 4 units first day
- 3 units on second day 2 units on third day (
- Conditions
- Organophosphorus Poisoning
- Being tested
- fresh frozen plasma
- Medical subject headings
- Organophosphate Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fresh frozen plasmaOther
repeated doses of fresh plasma over 3 days in organophosphate poisoned patients
| Study group | Role | What they receive |
|---|---|---|
| moderate group controlled patients | No intervention | Not described |
| moderate group study patients | Experimental | Not described Receives: Other: fresh frozen plasma |
| sever controlled group | No intervention | Not described |
| sever study group | Experimental | Not described Receives: Other: fresh frozen plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
fresh frozen plasma decrease the mortality rate among organophosphate poisoned patients
Measured: 3 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study startAug 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Organophosphorus PoisoningStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256796
- Sponsor's protocol ID
- plasma in OP poisoning
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dayananda VP, Bhaskara B, Pateel GN. A study of effectiveness of fresh frozen plasma in organophosphorous compound poisoning in reducing length of Intensive Care Unit stay and in reducing need for tracheostomy. Anesth Essays Res. 2016 May-Aug;10(2):268-72. doi: 10.4103/0259-1162.171455.
PubMed 27212759
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness of Fresh Frozen Plasma Transfusion as a Novel Adjuvant Treatment in Acute Organophosphate Poisoned Patients. A Randomized Clinical Trial in Poison Control Center Ain Shams University Hospital.
- ClinicalTrials.gov ID
- NCT06256796
- Acronym / sponsor ID
- plasma in OP poisoning
- Conditions
- Organophosphorus Poisoning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study clinical trial to assess the role of fresh frozen plasma as a novel available and easy to be applied rather than conventional therapy on organophosphate poisoned patients and prediction of it is prognosis on selected patients and it is effect on outcome .
Detailed description
a prospective randomized clinical trail study . this study will be conducted in poison control center Ain shas university hospital -Egypt . all adult patients of both sexes admitted , in Poison Control Center of Ain Shams University Hospitals (PCC-ASUH) with diagnosis of moderate and severe degree of organophosphate poisoning will be included in this study.
The severity of patients under the study will be assessed at the time of presentation using the PeradeniyaOrganophosphorus Poisoning (POP) scale The severity will be graded as mild(0-3), moderate (4-7), and sever (8- 11).
The included patients in this study will be randomly divided into two groups as follow:
Group A: Patients who will be treated according to traditional management protocol of OPC toxicity in the form of: supportive measures, decontamination and antidotal therapy (atropine \&Oximes) as follow:
- Supportive measures and patients resuscitation.
- Decontamination: patients presenting within 4hr of OP ingestion will be subjected to gastric lavage and all patients with oral exposure will be given a single (30 mg) dose of activated charcoal. Any contaminated material will be discarded and dermal contamination will be carried out using soap and water,if necessary.
- Antidotal therapy: Atropine(each ampoule contains 1mg of atropine per ml) will be given as bolus doses of 2-5 mg IV and repeated every10-15 min until dryness of chest secretions, and then atropine injections maintenance doses will be given intermittently to patients as needed .Toxogonin (each ampoule contains 250mg of obidoxime chloride in 1 ml, produced by Merck, Darmstadt, Germany)will be administered as a loading dose of 250 mg, and will be repeated every 8 hrs until at least 12hrs after atropine no longer required.
This group of patients will be divided in to :
GroupA1 will include moderate degree of acute OP poisoned patients (POP scale 4-7) Group A2 will include severe degree of acute OP poisoned patients (POP scale 8-11)
Group B: Patients who will be treated with conventional therapy of OPC toxicity in the form of: supportive measures, decontamination and antidotal therapy (atropine \&Oximes) in addition to fresh frozen plasma (FFP).
FFP will be given after one hour of hospitalization (time needed to prepare FFP to the patients and to finish emergency management) in dose of 20ml\kg given as follows:
- 4 units first day
- 3 units on second day 2 units on third day (
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| moderate group controlled patients | No intervention | – |
| moderate group study patients | Experimental | Other: fresh frozen plasma |
| sever controlled group | No intervention | – |
| sever study group | Experimental | Other: fresh frozen plasma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -moderate and severe degree of organophosphate poisoning will be included in this study.
Key exclusion criteria (6 listed)
- patients below 18 years or above 60 years.
- Patients with history of diabetes, cardiac disease, respiratory, renal disease and hepatic disease.
- Pregnant female
- Patients suspected of having mixed or unknown exposure
- Patients with coagulation disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fresh frozen plasmarepeated doses of fresh plasma over 3 days in organophosphate poisoned patients | Other | moderate group study patients, sever study group |
Primary outcome
mortality rate
Time frame: 3 monthes
fresh frozen plasma decrease the mortality rate among organophosphate poisoned patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 27212759Dayananda VP, Bhaskara B, Pateel GN. A study of effectiveness of fresh frozen plasma in organophosphorous compound poisoning in reducing length of Intensive Care Unit stay and in reducing need for tracheostomy. Anesth Essays Res. 2016 May-Aug;10(2):268-72. doi: 10.4103/0259-1162.171455.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fresh frozen plasma in people with Organophosphorus Poisoning, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (time frame: 3 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06256796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.